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GB 9706.1-2020 PDF in English


GB 9706.1-2020 (GB9706.1-2020) PDF English
Standard IDContents [version]USDSTEP2[PDF] delivered inName of Chinese StandardStatus
GB 9706.1-2020English1705 Add to Cart 0-9 seconds. Auto-delivery. Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance Valid
GB 9706.1-2007English685 Add to Cart 0-9 seconds. Auto-delivery. Medical electrical equipment -- Part 1: General requirements for safety Obsolete
GB 9706.1-1995EnglishRFQ ASK 10 days Medical electrical equipment--Part 1: General requirements for safety Obsolete
GB 9706.1-1988EnglishRFQ ASK 3 days Medical electrical equipment--Part 1: General requirements for safety Obsolete
Standards related to (historical): GB 9706.1-2020
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GB 9706.1-2020: PDF in English

GB 9706.1-2020 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040 C 30 Replacing GB 9706.1-2007, GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2012, MOD) ISSUED ON: APRIL 09, 2020 IMPLEMENTED ON: MAY 01, 2023 Issued by: State Administration for Market Regulation; Standardization Administration of the PRC. Table of Contents Foreword ... 4 1 Scope, object and related standards ... 11 2 Normative references ... 12 3 * Terminology and definitions ... 17 4 General requirements ... 51 5 * General requirements for testing ME EQUIPMENT ... 62 6 * Classification of ME EQUIPMENT and ME SYSTEMS ... 69 7 ME EQUIPMENT identification, marking and documents ... 70 8 * Protection against electrical HAZARDS from ME EQUIPMENT ... 96 9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ... 174 10 * Protection against unwanted and excessive radiation HAZARDS ... 204 11 Protection against excessive temperatures and other HAZARDS ... 207 12 * Accuracy of controls and instruments and protection against hazardous outputs ... 226 13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT 229 14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ... 238 15 Construction of ME EQUIPMENT ... 246 16 * ME SYSTEMS ... 265 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .. 274 Annex A (Informative) General guidance and rationale ... 275 Annex B (Informative) Sequence of testing ... 435 Annex C (Informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS ... 439 Annex D (Informative) Symbols on marking ... 443 Annex E (Informative) Examples of the connection of the measuring device (MD) for measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT (see 8.7) ... 452 Annex F (Informative) Suitable measuring supply circuits ... 454 Annex G (Normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures ... 457 Annex H (Informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation ... 476 Annex I (Informative) ME SYSTEMS aspects ... 487 Annex J (Informative) Survey of insulation paths (see 8.5.1) ... 493 Annex K (Informative) Simplified PATIENT LEAKAGE CURRENT diagrams ... 496 Annex L (Normative) Insulated winding wires for use without interleaved insulation (8.8.2) ... 499 Annex M (Normative) Reduction of pollution degrees (see 8.9.1.8) ... 503 Bibliography ... 504 Foreword All technical content of this Part is mandatory. GB 9706 "Medical electrical equipment" is divided into the following parts: - Part 1: General requirements for basic safety and essential performance; - Part 1-3: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV; - Part 2-2: Particular requirements for the safety of high frequency surgical equipment; - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment; - Part 2-4: Particular requirements for the safety of cardiac defibrillators; - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment; - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment; - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV; - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment; - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators; - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation; - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment; - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy after-loading equipment; - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment; - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators; - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment; - Part 2-24: Particular requirements for the safety of infusion pumps and controllers; - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs; - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph; - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment; - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis; - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators; - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy; - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment; - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment; - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures; - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography; - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices; - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy; - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment; - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment; - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment; - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems. This Part is Part 1 of GB 9706. This Part is drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces GB 9706.1-2007 "Medical electrical equipment - Part 1: General requirements for safety" and GB 9706.15-2008 "Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems". This Part is based on GB 9706.1-2007 and integrates all the contents of GB 9706.15-2008. Compared with GB 9706.1-2007, in addition to editorial changes, the main technical changes are as follows: - Incorporate the contents of GB 9706.15 and YY/T 0708 into this Part; - ADD requirements for essential performance (see Clause 4); - ADD the concept of expected service life (see 4.4); - ADD content related to risk management (see 4.2); - ADD different requirements for operator protection and patient protection (see Clause 8); - Modify the test requirements for protection against electric shock (see Clause 8; Clause 3 of the 2007 edition); - ADD relevant requirements for mechanical safety (see Clause 9); - ADD fire prevention requirements (see 11.3). This Part uses the redraft law to modify and adopt IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". The technical differences between this Part and IEC 60601-1:2012 and their reasons are as follows:  Replace IEC 60851-6:1996+AMD1:1997 with GB/T 4074.6-2008 identical to the international standard;  Replace IEC 60447 with GB/T 4205 identical to the international standard;  Replace IEC 60112 with GB/T 4207 identical to the international standard;  Replace IEC 60529:1989+AMD1:1999 with GB/T 4208 identical to the international standard;  Replace IEC 60335-1:2010 with GB 4706.1-2005 identical to the international standard;  Replace IEC 60950-1:2001 with GB 4943.1-2011 which modifies and adopts the international standard;  Replace IEC 60245-1:2003+AMD1:2007 with GB/T 5013.1-2008 identical to the international standard;  Replace IEC 60695-11-10 with GB/T 5169.16 identical to the international standard;  Replace IEC 60417 with GB/T 5465.2 identical to the international standard;  Replace IEC 60086-4 with GB 8897.4 identical to the international standard;  Replace IEC 60065:2001+AMD1:2005+AMD2:2010 with GB 8898- 2011 which modifies and adopts the international standard;  Replace IEC 60127-1 with GB/T 9364.1 which modifies and adopts the international standard;  Replace IEC 60601-1-3 with GB 9706.12 identical to the international standard;  Replace IEC 60085 with GB/T 11021 identical to the international standard;  Replace ISO 2878 with GB/T 11210 identical to the international standard;  Replace ISO 5349-1 with GB/T 14790.1 identical to the international standard; Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1 Scope, object and related standards 1.1 * Scope This Part of GB 9706 specifies the GENERAL REQUIREMENTS for BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS. This Part applies to MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this Part are not covered by specific requirements in this Part except in 7.2.13 and 8.4.1. Note 1: See also 4.2. The 9706 series does not apply to: - in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; - implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or - medical gas pipeline systems covered by ISO 7396-1 [68]. Note 2: ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS. Note 3: An asterisk (*) is used as the first character of the title or the beginning of a paragraph or table title, indicating that there are guidelines and rationale related to immersion “o” (GB/T 3836.6-2017, IEC 60079-6:2015, MOD) GB/T 3836.7 Explosive atmospheres - Part 7: Equipment protection by powder filling “q” (GB/T 3836.7-2017, IEC 60079-5:2015, MOD) GB/T 4026 Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors (GB/T 4026-2019, IEC 60445:2017, IDT) GB/T 4074.6-2008 Winding wires - Test methods - Part 6: Thermal properties (IEC 60851-6:1996, IDT) GB/T 4205 Basic and safety principles for man-machine interface (MMI), marking and identification - Actuating principles (GB/T 4205-2010, IEC 60447:2004, IDT) GB/T 4207 Method for the determination of the proof and the comparative tracking indices of solid insulating materials (GB/T 4207-2012, IEC 60112:2009, IDT) GB/T 4208 Degrees of protection provided by enclosure (IP code) (GB/T 4208-2017, IEC 60529:2013, IDT) GB 4706.1-2005 Household and similar electrical appliances - Safety - Part 1: General requirements [IEC 60335-1:2004 (Ed4.1), IDT] GB 4943.1-2011 Information technology equipment - Safety - Part 1: General requirements (IEC 60950-1:2005, MOD) GB/T 5013.1-2008 Rubber insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements (IEC 60245-1:2003, IDT) GB/T 5023.1-2008 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements (IEC 60227-1:2007, IDT) GB/T 5169.16 Fire hazard testing for electric and electronic products - Part 16: Test flames - 50 W horizontal and vertical flame test methods (GB/T 5169.16-2017, IEC 60695-11-10:2013, IDT) GB/T 5465.2 Graphical symbols for use on electrical equipment - Part 2: Graphical symbols (GB/T 5465.2-2008, IEC 60417:2007, IDT) GB/T 6346.14-2015 Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains (IEC 60384- 14:2005, IDT) GB 7247.1-2012 Safety of laser products - Part 1: Equipment classification and requirements (IEC 60825-1:2007, IDT) GB 8897.4 Primary batteries - Part 4: Safety of lithium batteries (GB 8897.4- 2008, IEC 60086-4:2007, IDT) GB 8898-2011 Audio, video and similar electronic apparatus - Safety requirements (IEC 60065:2005, MOD) GB/T 9364.1 Miniature fuses - Part 1: Definitions for miniature fuses and general requirement for miniature fuse-links (GB/T 9364.1-2015, IEC 60127- 1:2006, MOD) GB 9706.12 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (GB 9706.12-1997, idt IEC 60601-1-3:1994) GB/T 11021 Electrical insulation - Thermal evaluation and designation (GB/T 11021-2014, IEC 60085:2007, IDT) GB/T 11210 Rubber, vulcanized or thermoplastic - Antistatic and conductive products - Determination of electrical resistance (GB/T 11210-2014, ISO 2878:2011, IDT) GB/T 11918.1 Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements (GB/T 11918.1-2014, IEC 60309-1:2012, MOD) GB/T 11918.2 Plugs, socket-outlets and couplers for industrial purposes - Part 2: Dimensional compatibility and interchangeability requirements for pin and contact-tube accessories (GB/T 11918.2-2014, IEC 60309-2:2012, MOD) GB/T 14790.1 Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 1: General requirements (GB/T 14790.1-2009, ISO 5349-1:2001, IDT) GB/T 15092.1 Switches for appliances - Part 1: General requirements (GB/T 15092.1-2010, IEC 61058-1:2008, IDT) GB/T 16886 (all parts) Biological evaluation of medical devices [ISO 10993 (all parts)] GB/T 16895.21 Low-voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock (GB/T 16895.21-2011, IEC 60364- 4-41:2005, IDT) GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems - Part 1: Principles requirements and tests (IEC 60664-1:2007, IDT) GB/T 17465.1 Appliances couplers for household and similar general purposes - Part 1: General requirements (GB/T 17465.1-2009, IEC 60320- 1:2007, MOD) GB 18278.1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18278.1-2015, ISO 17665- 1:2006, IDT) GB 18279.1-2015 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007, IDT) GB 18280.1-2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, IDT) GB/T 19212.2 Safety of power transformers, power supplies, reactors and similar products - Part 2: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications (GB/T 19212.2-2012, IEC 61558-2-1:2007, IDT) GB/T 23821-2009 Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008, IDT) GB 27701 Mechanical safety of cathode ray tubes (GB 27701-2011, IEC 61965:2003, IDT) GB/T 28164 Secondary cells and batteries containing alkaline or other non- acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable application (GB/T 28164-2011, IEC 62133:2002, IDT) YY/T 0316-2016 Medical devices - Application of risk management to medical devices (ISO 14971:2007, IDT) YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT) YY 0505 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (YY 0505-2012, IEC 60601-1-2:2004, IDT) YY/T 0664-2008 Medical device software - Software life cycle processes (IEC 62304:2006, IDT) YY 0709 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (YY 0709-2009, IEC 60601-1-8:2003, IDT) ISO 2882 Rubber, vulcanized - Antistatic and conductive products for hospital use - Electrical resistance limits ISO 3864-1:2002 Graphical symbols - Safety colours and safety signs - Part 1: Design principles for safety signs in workplaces and public areas ISO 7000:2004 Graphical symbols for use on equipment - Index and synopsis ISO 7010:2011 Graphical symbols - Safety colours and safety signs - Registered safety signs ISO 9614-1 Determination of sound power levels of noise sources using sound intensity - Measurement at discrete points ISO 80000-1:2009 Quantities and units - Part 1: General IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability IEC 60730-1:2010 Automatic electrical controls - Part 1: General requirements IEC 60851-3:2009 Winding wires - Test methods - Part 3: Mechanical properties IEC 60851-5:2008 Winding wires - Test methods - Part 5: Electrical properties 3 * Terminology and definitions For the purposes of this document, the following terms and definitions apply. Note 1: Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. values of an alternating, direct or composite voltage or current unless stated otherwise. Note 2: The term “electrical equipment” is used to mean ME EQUIPMENT (see 3.63) or other electrical equipment. This Part also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM (see 3.64). ......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.